Manufacturer

Bard Access Systems

United StatesLegal entities : Bard Access Systems, Inc.

Markets : Belgium · Portugal · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 28 · class II · latest in 2025 · see on the FDA website

EU representative : Becton Dickinson Ireland Limited (Ireland)

2 categories, 15 models including 15 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Portable ultrasound scanners	Z11040103	BD Site-Rite™ 8 Ultrasound System93/42 BD Site~Rite® 8 Replacement Battery93/42 BD Site~Rite® 8 Ultrasound System 20mm Cue™ Linear Probe93/42 BD Site~Rite® 8 Ultrasound System 32mm Linear Probe2 refs93/42 BD Site~Rite® 8 Ultrasound System Console93/42 9 others BD Site~Rite® 8 Ultrasound System Cue™ Needle Tracking System Activator93/42 BD Site~Rite® 8 Ultrasound System Cue™ Needle Tracking System Activator Mounting Arm93/42 BD Site~Rite® 8 Ultrasound System Keyboard93/42 BD Site~Rite® 8 Ultrasound System Kickstand93/42 BD Site~Rite® 8 Ultrasound System Portable Kit93/42 BD Site~Rite® 8 Ultrasound System Power Supply93/42 BD Site~Rite® 8 Ultrasound System Probe Holder93/42 Not Applicable2 refs93/42 SiteRite BD Site-Rite™ 9 Ultrasound System3 refs	IIa MDR, 93/42	EUDAMED record Report an error
Ultrasound scanners - hardware accessories - other	Z1104018099	Not Applicable2 refs	I MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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